HydraGuard™ 10” UltraFilter - Flush, Instructions for Use
INTRODUCTION
Information on this sheet must be read before the use of this device to
ensure safe and effective operation.
Recommended Storage:
Between 5 and 35
°
C (41 and 95
°
F).
INDICATIONS
Description:
The HydraGuard 10” UltraFilter - Flush is a hollow fiber
ultrafilter that retains bacteria, viruses, and endotoxin from water.
Indications for Use:
The HydraGuard 10” UltraFilter - Flush is intended
to be used to filter EPA quality drinking water. The filter retains bacteria,
viruses and endotoxin. By providing ultrapure water for patient washing
and drinking, the filter aids in infection control. The filter produces
water that is suitable for patient wound cleansing, cleaning of
equipment used in medical procedures and washing of surgeon’s hands.
The filter is not intended to provide water that can be used as a
substitute for USP sterile water.
Use Life:
The device is intended for long term continuous use. Once it
completes its useful life, the filter should be replaced and discarded. Do
not attempt to sterilize or reuse it.
CONTRAINDICATIONS
Chemical:
The HydraGuard 10” UltraFilter - Flush retains biological
contaminants. To obtain chemically pure water it is necessary to use the
filter in conjunction with other devices such as DI beds or RO systems.
WARNINGS & PRECAUTIONS
Pressure & Temperature:
The HydraGuard 10” UltraFilter - Flush is
intended for a maximum incoming water pressure of 60 psi (4 bar) and
a maximum incoming temperature of 27°C (80°F).
Cyclic Use:
The HydraGuard 10” UltraFilter - Flush is designed to achieve
a maximum of 6,000 on/off cycles.
Replacement:
The filter should be replaced when the flow rate begins
to noticeably decrease. It is recommended to establish a maintenance
schedule of replacing the filter at least every 12 months dependent on
water quality.
Water Monitoring:
After installation of the HydraGuard 10” UltraFilter
- Flush, periodic monitoring of the water is recommended. Water
quality is dictated by the intended use and should be established and
monitored by the facilities engineer. Nephros is available to assist with
establishing guidelines and acceptance criteria as needed.
FILTER INSTALLATION & REMOVAL
New Install:
If this is the first time any reusable cartridge type filter is
being installed in a location (i.e. there are no cartridge housings in
place), please refer to the second page of these instructions for
installation guidance before proceeding with the instructions below.
Note:
Prior to handling a new filter, wash hands and wear disposable
gloves.
•
Turn off the water source upstream of the filter and vent any excess
pressure from the housing via its bleed valve or flush port valve.
•
Remove both the housing bowl/cover and the old filter.
Open a new filter blister pack and aseptically remove the filter.
•
Insert one end of the filter into the head of the housing cap. It may
be necessary to use a twisting motion to ensure that the filter is firmly
in place and the O-rings seat properly. Re-attach the housing
bowl/cover, to the housing cap.
•
Open the flush port valve and the upstream water source to prime
the new filter.
•
Close the flush port valve after 20-30 seconds, and continue to
prime the filter for 5 minutes to purge it of trapped air (if the
housing has a bleed valve, open it at the same time to assist
purging).
•
Close the outlet test valve (and bleed valves if present) and verify
there are no leaks.
OPERATION
After a new HydraGuard 10” UltraFilter - Flush is installed, water should
be run through the filter for approximately 5 minutes to purge it of
trapped air. The pressure drop across the HydraGuard 10” UltraFilter -
Flush generally reduces the flow rate by about 10-20% of the rate
without a filter. The HydraGuard 10” UltraFilter - Flush is designed with
a flush capability for periodic filter flushing. The filter should operate for
up to 12 months of normal use with minimal degradation in flow
(dependent on water quality and flush frequency). If the flow rate
degrades significantly, the filter should be replaced.
INTEGRITY TESTING
•
The filter integrity can be verified with a pressure holding test after
the filter has been properly primed and there are no connection
leaks.
•
Turn off the water source and open the inlet test valve to bleed off
any residual pressure.
•
Connect an air source (compressed air or air pump) to the inlet test
port as shown in
Housing and Filter Installation Example
. Note that a
pressure gauge must be installed to monitor the inlet filter pressure
to carry out this test.
•
Open both test valves, and pressurize the filter inlet; ensure the
outlet test port is venting. Raise the air pressure to 15 psi at the filter
inlet and allow water to exit from the outlet test port. Do not exceed
30 psi to prevent damage to the filter membrane.
•
When water stops coming out from the outlet test port close the
outlet test valve and check for external leaks (via pressure gauge).
•
Open the outlet test valve and re-pressurize as necessary to reach 15
psi at the filter inlet.
•
With the outlet test valve open, close the inlet test valve and allow
the pressure to stabilize for 5 to 10 seconds.
•
Monitor the pressure gauge and determine the pressure drop for a
period of 1 minute.
•
If the pressure drops by more than 1 psi over a minute, check for leaks
and repeat the test to confirm. If the filter fails, it must be replaced.
•
Close the outlet test valve and remove air source. Open water source
valve and re-prime filter to return to operation.
HydraGuard 10” UltraFilter – Flush, Clean Water Flow